Quality Engineer-Medical Device Coatings
Quality Engineer-Medical Device Coatings
Posted on :
22-05-2025
Employer Active
1 Vacancy
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Yearly Salary
USD 75000 - 95000
Vacancy
1 Vacancy
Posted on :
22-05-2025
Job Description
Annual Compensation Range: $75000$95000
Biocoatis committed to providing the best in developing manufacturing and applying coatings on medical devices.We are looking for a Quality Engineer to be part of a positive teamoriented environment. To be qualified and successful in this role a candidate will have work experience within a Quality Department and with Quality Management Systems (QMS).
Biocoat is the proud recipient of the Great Place to Work certification in 2025for the fourth time!
This role is an onsite position in Horsham PA.
Responsibilities:
Responsibilities include but are not limited to:
- Oversight of quality systems to meet applicable ISO 13485 and other regulatory requirements specifically in Design & Development Validation Change Control and Calibration
- Track trend and analyze manufacturing and quality performance to determine action required for development and continuous improvement
- Initiate process improvement projects to increase efficiency reduce costs simplify processes and improve quality
- Provide structure discipline and training to assure manufacturing and quality systems provide repeatable control are appropriate adequate and practiced
- Conduct and facilitate audits to ensure longterm compliance
- Conduct and support Nonconformance CAPA and Complaint investigations to determine root cause and corrective/preventive actions
- Coordinate and assist with validation activities including protocol and report generation review approval and execution
- Participate in and support Internal Customer and Regulatory Audits
- Interface with customers and suppliers to provide technical and quality support
- Develop and implement methods and standards for sampling inspection testing and evaluation of products
- Develop and implement statistical methods and design experiments to support process control and process/product improvement
- Assist in directing technicians engaged in measuring and testing products and tabulating data concerning products for process quality/reliability
- Bachelors degree required; Bachelors degree in a Life Science discipline is preferred but not required
- 35 years minimum experience in Quality Assurance or Quality Engineering environment
- Ability to work proficiently in a regulated manufacturing setting; lab related experience a plus
- Experience with ISO 9001 ISO 13485 or QSR Medical Device manufacturing and experience with QMS documentation and Good Documentation Practices required
- Knowledge of and firsthand experience with FDA / ISO medical device regulations required
- Process validation experience and involvement required
- Ability to report evaluate and interpret scientific data; peerreview as needed
- Excellent math skills to adequately perform and interpret calculations and test parameters
- Analytical approach to problem solving; critical thinker; uses data to substantiate decision making
- Proficiency with Microsoft Word Excel and Outlook; Prior experience with eQMS and/or ERP systems highly desired
- Independent; able to complete assigned tasks in a timely manner with minimal daytoday direction; keen attention to detail and ability to follow instructions
- Strong interpersonal skills and ability to work with and lead others at all levels in a positive and collaborative manner
- Must be a flexible team player capable of working in a deadline dictated environment
- Excellent oral and written technical communication skills with great proficiency in spelling grammar formatting and completeness of documentation
- Ability to effectively present in formal oneonone and group situations
- Organized with ability to identify and manage priorities; ownership of an issue or project to resolution; reliable followup and followthrough as needed
- Ability to follow and adhere to all Safety guidelines and processes including wearing appropriate lab gowning and other PPE as required
Work Environment:
Office environment with regular manufacturing and warehouse area exposure. Physical requirements are those that could be reasonably anticipated given the job duties and work environment. Travel is usually less than 5% between office locations and occasional incountry and international business travel.
Exposure to hazardous chemicals in certain areas of the office. Must wear required personal protective equipment while demonstrating safe working practices.
Physical Requirements
Physical Demands: Stooping turning bending squatting kneeling and the ability to lift up to 30 pounds; constant/repetitive standing; requires normal correctable vision and hearing and the ability to accurately discern color as necessary to perform job functions.
This position requires regular and sustained laboratory time around chemicals which may be hazardous. All personnel are required to follow all safety and chemical handling processes as outlined in various SOPs and Biocoats Chemical Hygiene Plan.
This position may work within a Class 7 cleanroom for periods of time. All personnel are required to follow Biocoats requirements for gowning and conduct while working within this environment.
What Biocoat Offers:
- Competitive salary eligible for a discretionary bonus
- Benefits (medical with HSA component dental vision critical illness and accident insurance)
- Life insurance short and longterm disability paid by the company
- Flexible Spending Accounts (FSAs)
- 401(k) plan with an immediate company match
- Paid time off
- Education Assistance Program
- Rewards and Recognition Program
- Parental Leave
- Employee Assistance Program
- Additional benefits such as the opportunity to leave early on Fridaysbusiness casual dress friendly work environment and fun company events.
Biocoat Human Resources leads recruitment and employment for Biocoat. Unsolicited resumes sent to Biocoat from recruiters do not constitute any type of relationship between the recruiter and Biocoat and do not obligate Biocoat to pay fees should we hire from those resumes. We ask those external recruiters and/or agencies not contact or present candidates
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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